Implantable medical device responsive to mri induced capture threshold changes

ABSTRACT

Energy delivered from an implantable medical device to stimulate tissue within a patient&#39;s body is controlled. An electrical signal used to stimulate the tissue is changed from a first energy state to a second energy state during a magnetic resonance imaging (MRI) scan. The energy delivered is maintained at the second energy state after the MRI scan. A capture threshold of the tissue is then measured, and the energy delivered to the tissue is adjusted based on the measured capture threshold of the tissue.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to Provisional Application No.61/102,027, filed Oct. 2, 2008, which is herein incorporated byreference in its entirety.

TECHNICAL FIELD

The present invention relates to implantable medical devices. Moreparticularly, the present invention relates to implantable medicaldevices that detect and compensate for magnetic resonance imaging (MRI)induced capture threshold changes.

BACKGROUND

Magnetic resonance imaging (MRI) is a non-invasive imaging method thatutilizes nuclear magnetic resonance techniques to render images within apatient's body. Typically, MRI systems employ the use of a magnetic coilhaving a magnetic field strength of between about 0.2 to 3.0 Tesla.During the procedure, the body tissue is also briefly exposed to radiofrequency (RF) pulses of electromagnetic energy. The relaxation ofproton spins following cessation of the RF pulses can be used to imagethe body tissue.

During imaging, the electromagnetic radiation produced by the MRI systemcan be picked up by implantable device leads used in implantable medicaldevices such as pacemakers or cardiac defibrillators. This energy may betransferred through the lead to the electrode in contact with thetissue, which can cause elevated temperatures at the point of contact.The degree of tissue heating is typically related to factors such as thelength of the lead, the conductivity or impedance of the lead, and thesurface area of the lead electrodes. The effectiveness of implantedcardiac management devices may be compromised by the heating of cardiactissue at the lead/heart interface. For example, pacemakers deliver lowenergy pace pulses that cause the heart to initiate a beat. The minimumvoltage of those pace pulses that results in a response from the heartis known as the capture threshold. The capture threshold may increase asa result of localized heating of the lead due to the MRI RF field.Consequently, with an elevated capture threshold for the cardiac tissue,the implantable medical device may not deliver a pulse of sufficientvoltage to generate a desired response in the tissue (i.e., loss ofcapture).

SUMMARY

In one aspect, the present invention relates to controlling energydelivered from an implantable medical device to stimulate tissue withina patient's body. An electrical signal used to stimulate the tissue ischanged from a first energy state to a second energy state during amagnetic resonance imaging (MRI) scan. The energy delivered ismaintained at the second energy state after the MRI scan. A capturethreshold of the tissue is then measured, and the energy delivered tothe tissue is adjusted based on the measured capture threshold of thetissue.

In another aspect, the present invention relates to controlling energydelivered from an implantable medical device to stimulate tissue. Energyhaving a first energy state is delivered to stimulate the tissue.Magnetic resonance imaging (MRI) scan fields (e.g., magnetic and/orelectromagnetic fields) are detected, and the energy delivered isincreased from the first energy state to a second energy state. Theenergy delivered is maintained at the second energy state after the MRIscan fields are no longer detected. A capture threshold of the tissue isthen measured, and the energy delivered by the implantable medicaldevice is adjusted, if necessary, based on the measured capturethreshold of the tissue.

In a further aspect, the present invention relates to an implantablemedical device including an electrode configured to contact tissue in abody vessel and a lead having a lead conductor connected to theelectrode. Sensing circuitry receives signals through the lead based onelectrical activity of the tissue, and therapy circuitry deliverselectrical stimulation to the tissue through the lead. Magnetic fielddetection circuitry detects magnetic resonance imaging (MRI) scanfields. Control circuitry is operable to set a level of energy deliveredby the therapy circuitry to stimulate the tissue to an MRI mode energystate when the magnetic detection circuitry detects the MRI scan fields.After the magnetic field detection circuitry no longer detects the MRIscan fields, the control circuitry adjusts the level of energy deliveredbased on a capture threshold of the tissue periodically measured by thesensing circuitry.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic drawing of a cardiac rhythm management systemincluding a pulse generator coupled to a lead deployed in a patient'sheart.

FIG. 2 is a functional block diagram of an implantable medical deviceconfigured to detect and compensate for magnetic resonance imaging (MRI)induced capture threshold changes according to an embodiment of thepresent invention.

FIG. 3 is a functional block diagram of an external device operable tocommunicate with the implantable medical device of FIG. 2.

FIG. 4 is a flow diagram of a process for compensating for magneticresonance imaging (MRI) induced capture threshold changes according toan embodiment of the present invention.

While the invention is amenable to various modifications and alternativeforms, specific embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular embodiments described. Onthe contrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claims.

DETAILED DESCRIPTION

FIG. 1 is a schematic view of a cardiac rhythm management system 10including an implantable medical device (IMD) 12 with a lead 14 having aproximal end 16 and a distal end 18. In one embodiment, the IMD 12includes a pulse generator. The IMD 12 can be implanted subcutaneouslywithin the body, typically at a location such as in the patient's chestor abdomen, although other implantation locations are possible. Theproximal end 16 of the lead 14 can be coupled to or formed integrallywith the IMD 12. The distal end 18 of the lead 14, in turn, can beimplanted at a desired location in or near the heart 16. The system 10may also include one or more external devices 19 (e.g., a computingdevice and/or programming device), which may communicate with the IMD 12from outside of the patient's body wirelessly.

As shown in FIG. 1, distal portions of lead 14 are disposed in apatient's heart 20, which includes a right atrium 22, a right ventricle24, a left atrium 26, and a left ventricle 28. In the embodimentillustrated in FIG. 1, the distal end 18 of the lead 14 is transvenouslyguided through the right atrium 22, through the coronary sinus ostium29, and into a branch of the coronary sinus 31 or the great cardiac vein33. The illustrated position of the lead 14 can be used for sensing orfor delivering pacing and/or defibrillation energy to the left side ofthe heart 20, or to treat arrhythmias or other cardiac disordersrequiring therapy delivered to the left side of the heart 20.Additionally, while the lead 14 is shown disposed in the left ventricle28 of the heart, the lead 14 can alternatively be used to providetreatment in other regions of the heart 20 (e.g., the right ventricle24).

Although the illustrative embodiment depicts only a single lead 14inserted into the patient's heart 20, it should be understood thatmultiple leads can be utilized so as to electrically stimulate otherareas of the heart 20. In some embodiments, for example, the distal endof a second lead (not shown) may be implanted in the right atrium 18. Inaddition, or in lieu, another lead may be implanted in or near the rightside of the heart 20 (e.g., in the coronary veins) to stimulate theright side of the heart 20. Other types of leads such as epicardialleads may also be utilized in addition to, or in lieu of, the lead 14depicted in FIG. 1.

During operation, the lead 14 can be configured to convey electricalsignals between the IMD 12 and the heart 20. For example, in thoseembodiments where the IMD 12 is a pacemaker, the lead 14 can be utilizedto deliver electrical therapeutic stimulus for pacing the heart 20. Inthose embodiments where the IMD 12 is an implantable cardiacdefibrillator, the lead 14 can be utilized to deliver electric shocks tothe heart 20 in response to an event such as a heart attack orarrhythmia. In some embodiments, the IMD 12 includes both pacing anddefibrillation capabilities.

When the IMD 12 is subjected to a magnetic field from an MRI scanner orother external magnetic source, electromagnetic radiation is deliveredto the patient's body that can be picked up by the lead 14 andtransferred to one or more lead electrodes 36 in contact with the bodytissue. This electromagnetic radiation can cause heating at theinterface of the lead electrodes 36 and body tissue. This can affect thecapture threshold of the heart 20, which is the stimulus amplitudeand/or duration of the electrical signals provided by the IMD 12 to theheart 20 that cause the heart 20 to beat.

FIG. 2 is a functional block diagram of an embodiment of the IMD 12configured to detect and compensate for MRI induced capture thresholdchanges. The IMD 12 includes an energy storage device 40, a controller42, a sensing/therapy module 44, a communication module 46, and an MRIdetect module 48. The term “module” is not intended to imply anyparticular structure. Rather, “module” may mean components and circuitryintegrated into a single unit as well as individual, discrete componentsand circuitry that are functionally related. In addition, it should benoted that IMD 12 may include additional functional modules that areoperable to perform other functions associated with operation of IMD 12.

The energy storage device 40 operates to provide operating power to thecontroller 42, the sensing/therapy module 44, the communication module46, and the MRI detect module 48. The controller 42 operates to controlthe sensing/therapy module 44, the communication module 46, and the MRIdetect module 48, each of which is operatively coupled to andcommunicates with the controller 42. For example, the controller 42 maycommand the sensing/therapy module 44 to deliver a desired therapy, suchas a pacing or defibrillation stimulus, or to determine the capturethreshold of the tissue to which the electrodes 36 are coupled. Inaddition, the controller 42 may command the communication module 46 totransmit and/or receive data from the external device 19. Furthermore,the controller 42 may receive signals from the MRI detect module 48indicating the presence or absence of electromagnetic radiationgenerated by an MRI scan.

The IMD 12 may also include timing circuitry (not shown) which operatesto schedule, prompt, and/or activate the IMD 12 to perform variousactivities. In one embodiment, the timing circuitry is an internal timeror oscillator, while in other embodiments, timing may be performed byspecific hardware components that contain hardwired logic for performingthe steps, or by any combination of programmed computer components andcustom hardware components.

The communication module 46 is configured to both transmit and receivetelemetry signals to and from other devices, such as the external device19. In other embodiments, the IMD 12 includes at least one transducerconfigured for receiving a telemetry signal and at least one transducerfor transmitting a telemetry signal. The wireless transducer 26 may beany type of device capable of sending and/or receiving information via atelemetry signal, including, but not limited to, a radio frequency (RF)transmitter, an acoustic transducer, or an inductive transducer.

The sensing/therapy module 44 operates to perform the therapeutic and/ordiagnostic functions of the IMD 12. In one embodiment, thesensing/therapy module 44 delivers a cardiac pacing and/ordefibrillation stimulus. The sensing/therapy module 44 is not limited toperforming any particular type of physiologic measurement or therapy,and may be configured to perform other types of physiologic measurementsand therapy, such as neurological measurements and therapy. Thesensing/therapy module 44 is also operable to automatically determinethe capture threshold of the heart 20 by providing a pacing stimulus tothe heart 20 and sensing whether the stimulus results in a contractionof the heart 20. In some embodiments, the sensing/therapy module 44delivers a sequence of pacing pulses of varying magnitude and/orduration to the heart 20 and senses a response of the tissue to thepacing pulses to determine whether the pulses have a large enoughduration and/or magnitude to stimulate the heart 20. One example circuitarrangement that may be included in sensing/therapy module 44 todetermine the capture threshold of heart 20 is disclosed in U.S. Pat.No. 7,092,756, entitled “Autocapture Pacing/Sensing Configuration,”which is incorporated herein by reference in its entirety.

The MRI detect module 48 senses the presence of the magnetic and/orelectromagnetic fields associated with an MRI scan. In some embodiments,the MRI detect module 48 includes a power inductor and a core saturationdetector. When the power inductor saturates in the presence of an MRIfield, the inductance of the power inductor decreases, which is detectedby the core saturation detector. One example module having such aconfiguration that is suitable for use in MRI detect module 48 isdisclosed in U.S. patent application Ser. No. 11/276,159, entitled “MRIDetector for Implantable Medical Device,” which is incorporated hereinby reference in its entirety. Any type of sensor or device mayalternatively or additionally be incorporated into the MRI detect module48 that is operable to detect the presence of MRI fields. Examplesensors or devices that may be included in the MRI detect module 48include, but are not limited to, a Hall effect sensor, amagnetotransistor, a magnetodiode, a magneto-optical sensor, and/or agiant magnetoresistive sensor.

When the MRI detect module 48 detects the presence of an MRI field, theMRI detect module 48 sends a signal to the controller 42. The controller42 may then switch operation of the IMD 12 from a normal mode ofoperation to an MRI mode of operation. Alternatively, the IMD 12 may beprogrammed to the MRI mode of operation, for example by using theexternal device 19. The MRI mode of operation may include non-sensingfixed rate bradycardia pacing (described in more detail below),disablement of tachycardia therapy, or any mode of operation that issafe and desirable in a high electromagnetic field environment wheresensing of cardiac activity may be compromised.

FIG. 3 is a functional block diagram illustrating an embodiment of theexternal device 19 shown in FIG. 1. The external device 19 includes acommunication module 52, a controller 54, an audio/visual user feedbackdevice 56, and an input device 58. In some embodiments, the externaldevice 19 is a device for use by a caregiver for communicating with theIMD 12. The external device 19 may include an interface for connectingto the Internet, to a cell phone, and/or to other wired or wirelessmeans for downloading or uploading information and programs, debuggingdata, and upgrades.

The communication module 52 for the external device 19 is configured toboth transmit and receive signals to and from the IMD 12. In otherembodiments, the external device 19 includes at least one transducerconfigured to receive a signal and at least one transducer fortransmitting a signal. The communication module 52 may be any type ofdevice capable of communicating with the communication module 46 of theIMD 12 including, but not limited to, an RF transmitter, an acoustictransducer, or an inductive transducer.

In some embodiments, the controller 54 includes a processor foranalyzing, interpreting, and/or processing the received signals, and amemory for storing the processed information and/or commands for useinternally. For example, the controller 54 may be used to analyzesignals related to the capture threshold of the heart 20 from the IMD12. The controller 54 can be configured as a digital signal processor(DSP), a field programmable gate array (FPGA), an application specificintegrated circuit (ASIC) compatible device such as a CoolRISC processoravailable from Xemics or other programmable devices, and/or any otherhardware components or software modules for processing, analyzing,storing data, and controlling the operation of the external device 19.

The user feedback device 56 may include a screen or display panel forcommunicating information to the clinician and/or to the patient. Insome embodiments, the screen or display panel is configured to displayoperational information about the IMD 12. For example, the screen ordisplay panel may display visual information indicative of the capturethreshold of the heart 20 as received from the IMD 12 for use inassessing whether the active pacing signals are sufficient to stimulatethe heart 20.

The input device 58 includes an interface through which a clinician mayinput information or commands to be executed by the external device 19.In some embodiments, the input device 58 is a keyboard. For example, ifinformation about the capture threshold test conducted by thesensing/therapy module 44 of the IMD 12 is provided on the user feedbackdevice 56, the clinician may provide an input to the external device 19through the input device 58 to communicate pacing signal configurationinformation to the IMD 12 based on the information about the capturethreshold test.

FIG. 4 is a flow diagram of a process for controlling the IMD 12 duringand after an MRI scan to assure that the heart 20 is stimulated bysignals provided by the sensing/therapy module 44. The MRI detect module48 detects the presence of MRI fields. Then, in step 60, the controller42 changes the stimulation energy provided by the sensing/therapy module44 from a first, pre-MRI energy state to a second, MRI mode energy stateto assure capture of the tissue of the heart 20. In some embodiments,the controller 42 may be programmed to control the sensing/therapymodule 44 to provide pacing pulses having a predetermined signalamplitude and/or duration in the presence of an MRI field. In someembodiments, the second energy state has a greater amplitude and/orduration than the first energy state, since the MRI fields can increasethe capture threshold of the heart 20. The second energy state may beprogrammed into the controller 42, or the second energy state may bedetermined by the sensing/therapy module 44 using capture detectionalgorithm discussed above. Alternatively, the second energy state may beprovided to the IMD 12 via the external device 19.

When the MRI detect module 48 senses the absence of the MRI fields(i.e., when the MRI scan is completed), the MRI detect module 48 sends asignal to the controller 42 to suspend the MRI mode of operation.Alternatively, the controller 42 may suspend the MRI mode of operationafter a predetermined period of time (e.g., one hour) based on ananticipated length of the MRI scan. In any case, in step 62, thecontroller 42 maintains the stimulation energy provided by thesensing/therapy module 44 at the second energy state after the MRI scan.This is because the capture threshold of the heart 20 may remainelevated after the MRI scan, since the tissue of the heart 20 does notimmediately recover from the effects of the MRI fields. This assuresthat proper pacing is maintained while the tissue is residually affectedby the MRI scan.

In step 64, the controller 54 then commands the sensing/therapy module44 to measure the capture threshold of the tissue of the heart 20. Asdiscussed above, the sensing/therapy module 44 may deliver a sequence ofpacing pulses of varying magnitude and/or duration to the tissue andsense the response of the tissue to the pacing pulses. Thesensing/therapy module 44 may conduct the capture threshold testautomatically after a programmed period of time from when the MRI detectmodule 48 senses that the MRI field is no longer present, or after aprogrammed period of time independent of when the MRI field was lastdetected. Alternatively, the sensing/therapy module 44 may conduct thecapture threshold test in response to signals from the external device19. The medical personnel controlling the external device 19 maymanually determine the proper capture threshold based on signalsgenerated by the sensing/therapy module 44 during the capture thresholdtest. If the determination of the capture threshold is not successful,then the sensing/therapy module 44 maintains the stimulation energy atthe second energy state.

If the sensing/therapy module 44 determines the capture thresholdsuccessfully, then, in step 66, the controller 42 controls thesensing/therapy module 44 to adjust the stimulation energy provided topace the heart 20 based on the measured capture threshold. This may beperformed automatically by the IMD 12 or in response to signals providedby the external device 19. Thus, if the sensing/therapy module 44determines that the capture threshold has decreased from the secondenergy state (i.e., the MRI mode stimulation state), the controller 42reduces the energy state (i.e., the amplitude and/or duration) of thestimulation pulses to correspond to the decreased capture threshold.This assures that the draw on the energy storage device 40 is minimizedwhile at the same time assuring proper energy and pace amplitude isprovided to the heart 20 for stimulation.

In some embodiments, steps 54 and 56 are repeated by the IMD 12 until aphysiological event occurs. For example, steps 54 and 56 may beperiodically or intermittently repeated until the capture thresholdreturns to the first, pre-MRI stimulation energy state. This assuresthat the IMD 12 provides proper pacing stimulation until the heart 20 isno longer affected by the MRI fields. As another example, steps 54 and56 may be repeated until the capture threshold remains steady for aprogrammed number of capture threshold tests. Thus, even if the capturethreshold does not return to the first, pre-MRI stimulation energystate, the IMD 12 operates to provide pacing pulses at a levelsufficient to stimulate the tissue.

In summary, the present invention relates to controlling energydelivered from an implantable medical device to stimulate tissue. Energydelivered to stimulate the tissue is changed from a first energy stateto a second energy state during a magnetic resonance imaging (MRI) scan.The energy delivered is maintained at the second energy state after theMRI scan. A capture threshold of the tissue is then measured, and thelevel of energy delivered to the tissue is adjusted based on themeasured capture threshold of the tissue. By monitoring the capturethreshold after the MRI scan, the implantable medical device delivers asufficient level of energy to stimulate the tissue when the tissue isresidually affected by the MRI scan.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. While the embodiments described above refer to particularfeatures, the scope of this invention also includes embodiments havingdifferent combinations of features and embodiments that do not includeall of the described features. For example, while the present inventionhas been described with regard to cardiac pacing, the principles of thepresent invention are also applicable to other types of systems withstimulation properties that may be altered by MRI fields, such asneurological therapy systems. In addition, while the system describeduses electrical signals to stimulate tissue, other types of controlagents may be employed to compensate for the effects of the MRI fieldson the tissue, such as by chemical stimulation. Accordingly, the scopeof the present invention is intended to embrace all such alternatives,modifications, and variations as fall within the scope of the claims,together with all equivalents thereof.

1. A method for controlling energy delivered from an implantable medicaldevice to stimulate body tissue within a patient, the method comprising:changing energy delivered to stimulate the tissue from a first energystate to a second energy state during a magnetic resonance imaging (MRI)scan; maintaining the energy delivered at the second energy state afterthe MRI scan; measuring a capture threshold of the tissue; and adjustingthe energy delivered based on the measured capture threshold of thetissue.
 2. The method of claim 1, wherein the measuring and adjustingsteps are repeated until the energy delivered returns to the firstenergy state.
 3. The method of claim 1, wherein the measuring andadjusting steps are repeated until the measured capture thresholdremains substantially unchanged for a programmed number of capturethreshold measurements.
 4. The method of claim 1, wherein measuring thecapture threshold of the tissue comprises: delivering a sequence ofpacing pulses of varying magnitude to the tissue; and sensing a responseof the tissue to the pacing pulses.
 5. The method of claim 1, whereinmeasuring the capture threshold of the tissue comprises: delivering asequence of pacing pulses of varying duration to the tissue; and sensinga response of the tissue to the pacing pulses.
 6. The method of claim 1,wherein the measuring and adjusting steps are performed by theimplantable medical device.
 7. The method of claim 1, wherein themeasuring and adjusting steps are controlled by an external device incommunication with the implantable medical device.
 8. The method ofclaim 1, wherein the second energy state has a signal magnitude and/orduration greater than the first energy state.
 9. A method forcontrolling energy delivered from an implantable medical device tostimulate body tissue within a patient, the method comprising:delivering energy having a first energy level to stimulate the tissue;detecting magnetic resonance imaging (MRI) scan fields; increasing theenergy delivered from the first energy level to a second energy level;maintaining the energy delivered at the second energy level after theMRI scan fields are no longer detected; measuring a capture threshold ofthe tissue; and adjusting the energy delivered by the implantablemedical device based on the measured capture threshold of the tissue.10. The method of claim 9, wherein the measuring and adjusting steps arerepeated until the level of energy delivered by the implantable medicaldevice is returned to the first energy level.
 11. The method of claim 9,wherein measuring the capture threshold of the tissue comprises:delivering a sequence of pacing pulses of varying magnitude to thetissue; and sensing a response of the tissue to the pacing pulses. 12.The method of claim 9, wherein the measuring and adjusting steps areperformed by the implantable medical device.
 13. The method of claim 9,wherein the measuring and adjusting steps are controlled by an externaldevice in communication with the implantable medical device.
 14. Animplantable medical device comprising: a lead including an electrodeadapted to electrically stimulate body tissue; sensing circuitryoperable to receive signals through the lead based on electricalactivity of the tissue; therapy circuitry operable to deliver electricalstimulation to the tissue through the lead, wherein the sensing andtherapy circuitry is further operable to measure a capture threshold ofthe tissue; magnetic field detection circuitry operable to detectmagnetic resonance imaging (MRI) scan fields; and control circuitryoperable to set energy delivered by the therapy circuitry to stimulatethe tissue from a normal energy state to an MRI mode energy state whenthe magnetic detection circuitry detects the MRI scan fields, and, afterthe magnetic field detection circuitry no longer detects the MRI scanfields, to adjust the energy delivered based on the measured capturethreshold of the tissue.
 15. The implantable medical device of claim 14,wherein the control circuitry maintains the energy delivered by thetherapy circuitry at the MRI mode energy level for a period of timeafter the magnetic field detection circuitry no longer detects the MRIscan fields.
 16. The implantable medical device of claim 14, wherein thecontrol circuitry repeatedly adjusts the energy delivered based on themeasured capture threshold until the energy delivered returns to thenormal energy state.
 17. The implantable medical device of claim 14,wherein, to measure the capture threshold, the therapy circuitrydelivers a sequence of pacing pulses of varying magnitude and/orduration to the tissue, and the sensing circuitry senses a response ofthe tissue to the pacing pulses.
 18. The implantable medical device ofclaim 14, wherein the sensing circuitry measures the capture thresholdof the tissue and the control circuitry adjusts the energy delivered inresponse to a control signal from an external device.
 19. Theimplantable medical device of claim 14, wherein the sensing circuitry,therapy circuitry, magnetic field detection circuitry, and controlcircuitry are included in a pulse generator.
 20. The implantable medicaldevice of claim 14, and further comprising: communication circuitryoperable to communicate information about the measured capturethreshold.